Preparation methods for transcatheter heart valve delivery systems

ABSTRACT

A delivery device for a collapsible prosthetic heart valve includes a support shaft around which a compartment is defined, an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen therethrough, and a distal sheath operatively connected at a distal end to the inner shaft and slidable therewith. The compartment may receive the valve in an assembled condition, and may be selectively covered and uncovered by the distal sheath. A first flow path may provide flow communication between the lumen of the inner shaft and the compartment.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/383,982, filed Sep. 17, 2010, entitled “ImprovedPreparation Methods for Transcatheter Heart Valve Delivery Systems,” thedisclosure of which is hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention is related to prosthetic heart valve replacement,and more particularly to devices, systems, and methods for transcatheterdelivery of collapsible prosthetic heart valves.

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two types of stents on which thevalves structures are ordinarily mounted: a self-expanding stent and aballoon-expandable stent. To place such valves into a delivery apparatusand ultimately into a patient, the valve must first be collapsed orcrimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the entire valve, assuring its properlocation, and then expanding a balloon positioned within the valvestent. For self-expanding valves, on the other hand, the stentautomatically begins to expand as the sheath covering the valve iswithdrawn. Once a self-expanding valve has been fully deployed, itexpands to a diameter larger than that of the sheath that previouslyretained the valve in the collapsed condition.

Despite the various improvements that have been made to the collapsibleprosthetic heart valve delivery process, conventional delivery devices,systems, and methods suffer from some shortcomings. There therefore is aneed for further improvements to the devices, systems, and methods fortranscatheter delivery of collapsible prosthetic heart valves.

BRIEF SUMMARY OF THE INVENTION

A delivery device for a collapsible prosthetic heart valve, a deliverysystem for a collapsible prosthetic heart valve, and a method offlushing a delivery device for a collapsible prosthetic heart valve aredisclosed.

A delivery device for a collapsible prosthetic heart valve includes asupport shaft around which a compartment is defined, the compartmentbeing adapted to receive the valve in an assembled condition, an innershaft extending through the support shaft and adapted to slide relativeto the support shaft along a longitudinal axis thereof, the inner shafthaving a lumen therethrough, a distal sheath operatively connected at adistal end to the inner shaft and slidable therewith, the distal sheathbeing adapted to selectively cover and uncover the compartment and thevalve, and a first flow path providing flow communication between thelumen of the inner shaft and the compartment.

The delivery device may also include a distal tip operatively connectedto a distal end of the inner shaft, a distal retainer interposed betweenthe distal tip and the compartment, and a pocket defined between thedistal retainer and the distal tip. The delivery device may also includea second flow path providing flow communication between the pocket andthe compartment. The second flow path may include at least onethrough-hole in the distal retainer. The first flow path may include anaperture in a wall of the inner shaft providing flow communicationbetween the lumen of the inner shaft and the pocket. The delivery devicemay also include an insert disposed in the pocket and defining an emptyspace between the insert and the distal tip, the empty space being inflow communication with the lumen of the inner shaft, the insertincluding one or more liquid passages extending between the empty spaceand the pocket. The delivery device may also include a proximal retainerlocated at a proximal end of the compartment, and a cylindrical gapdefined between a free end of the distal sheath and the proximalretainer.

A delivery device for a collapsible prosthetic heart valve includes asupport shaft around which a compartment is defined, the compartmentbeing adapted to receive the valve in an assembled condition, an innershaft extending through the support shaft and adapted to slide relativeto the support shaft along a longitudinal axis thereof, the inner shafthaving a lumen therethrough, a distal sheath having a distal endoperatively connected to the inner shaft and slidable therewith, thedistal sheath being adapted to selectively cover and uncover thecompartment and the valve, and a distal tip operatively connected to adistal end of the inner shaft, the distal tip having a passage thereinproviding flow communication between an exterior of the delivery deviceand the compartment. The passage may be adapted to self-seal such thatliquid can not flow therethrough from the compartment to the exterior ofthe delivery device.

A delivery system for a collapsible prosthetic heart valve includes asupport shaft around which a compartment is defined, the compartmentbeing adapted to receive the valve in an assembled condition, an innershaft extending through the support shaft and adapted to slide relativeto the support shaft along a longitudinal axis thereof, the inner shafthaving a lumen therethrough in flow communication with an exterior ofthe delivery device, a distal sheath operatively connected at a distalend to the inner shaft and slidable therewith, the distal sheath beingadapted to selectively cover and uncover the compartment and the valve,a first flow path providing flow communication between the lumen of theinner shaft and the compartment, and a removable plug adapted forconnection to the delivery device to occlude the flow communicationbetween the lumen of the inner shaft and the exterior of the deliverydevice.

The delivery system may also include a removable cap adapted forconnection to a proximal end of the inner shaft to create a liquid-tightseal at the proximal end of the inner shaft. The delivery system mayalso include a distal tip operatively connected to a distal end of theinner shaft, and a flushing needle having a hollow needle shaft adaptedto supply a flushing liquid to the compartment through the distal tip.The delivery system may also include a distal tip operatively connectedto a distal end of the inner shaft, a distal retainer interposed betweenthe distal tip and the compartment, and a pocket defined between thedistal retainer and the distal tip. The delivery system may also includea second flow path providing flow communication between the pocket andthe compartment. The second flow path may include at least onethrough-hole in the distal retainer. The first flow path may include anaperture in a wall of the inner shaft providing flow communicationbetween the lumen of the inner shaft and the pocket. The delivery devicemay also include an insert disposed in the pocket and defining an emptyspace between the insert and the distal tip, the empty space being inflow communication with the lumen of the inner shaft, the insertincluding one or more liquid passages extending between the empty spaceand the pocket.

A method of flushing a delivery device for a collapsible prostheticheart valve may include providing a delivery device including a supportshaft around which a compartment is defined, an inner shaft extendingthrough the support shaft and adapted to slide relative to the supportshaft along a longitudinal axis thereof, and a distal sheath having adistal end operatively connected to the inner shaft and a proximal end,the distal sheath being slidable with the inner shaft, mounting acollapsible prosthetic heart valve in the compartment, sliding thedistal sheath to cover the compartment and the valve, and flushing aliquid through the compartment from a distal end of the compartment to aproximal end of the compartment.

The flushing step may include flowing the liquid out of the compartmentthrough an opening at the proximal end of the distal sheath. Theflushing step may include flowing the liquid through a lumen in theinner shaft in a direction from a proximal end of the inner shaft towarda distal end of the inner shaft, and flowing the liquid from the lumenof the inner shaft to the compartment. The flushing step may includeflowing the liquid from the lumen of the inner shaft to the compartmentthrough an aperture in a wall of the inner shaft. The delivery devicemay also include a distal tip operatively connected to the distal end ofthe inner shaft, a distal retainer interposed between the distal tip andthe compartment, a pocket defined between the distal retainer and thedistal tip, and an insert disposed in the pocket and defining an emptyspace between the insert and the distal tip. The flushing step mayinclude flowing the liquid from the lumen of the inner shaft to theempty space, from the empty space through the insert to the pocket, andfrom the pocket through the distal retainer to the compartment. Theflushing step may include flowing the liquid through a lumen in theinner shaft in a direction from a distal end of the inner shaft toward aproximal end of the inner shaft, and flowing the liquid from the lumenof the inner shaft to the compartment. The delivery device may alsoinclude a distal tip operatively connected to a distal end of the innershaft, the distal tip having a passage therein. The flushing step mayinclude flowing the liquid through the passage into the distal end ofthe compartment.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be discussed withreference to the appended drawings. It is appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

FIG. 1 is a highly schematic side elevational view of a transapicaldelivery device for a collapsible prosthetic heart valve according to anembodiment of the invention, shown in partial cross-section andillustrating an exemplary flow of flushing liquid through the device;

FIG. 2 is an enlarged partial cross-sectional view of a liquidcommunication assembly suitable for use in the delivery device of FIG.1;

FIG. 3 is a highly schematic side elevational view of a transapicaldelivery device for a collapsible prosthetic heart valve according toanother embodiment of the present invention, shown in partialcross-section with a flushing needle; and

FIG. 4 is a highly schematic side elevational view of a transapicaldelivery device for a collapsible prosthetic heart valve according to afurther embodiment of the present invention, shown in partialcross-section with a flushing needle.

DETAILED DESCRIPTION

As used herein, the terms “proximal” and “distal” are to be taken asrelative to a user (e.g., a surgeon or an interventional cardiologist)using the disclosed delivery devices. “Proximal” is to be understood asrelatively close to the user and “distal” is to be understood asrelatively farther away from the user.

Referring to FIG. 1, an exemplary transapical delivery device 10 for acollapsible prosthetic heart valve 6 extends from a proximal end (notshown) to a distal tip 14 and includes a catheter assembly 16 fordelivering the heart valve to and deploying the heart valve at a targetlocation. The catheter assembly 16 is adapted to receive the collapsibleprosthetic heart valve 6 in an assembled condition in a compartment 23defined around a support shaft 21. A distal sheath 24 is operable forsliding movement between a closed position covering the prosthetic heartvalve 6 and maintaining it in a collapsed condition, and an openposition for deployment of the valve.

The support shaft 21 extends between a pair of spaced retainers 17 and30 affixed thereto and defining the ends of the compartment 23. Theretainer 30 is adapted to hold the aortic end of the prosthetic heartvalve 6. The delivery device further includes an outer shaft 22, thedistal end of which is connected to the retainer 17, and the proximalend of which can optionally be connected to a hub (not shown) that canbe held by a user when sliding the distal sheath 24 relative to thesupport shaft 21.

An inner shaft 26 extends from the proximal end of the delivery devicethrough the outer shaft 22 and the support shaft 21 for connection tothe distal tip 14. The inner shaft 26 has a lumen 25 for receiving aguide wire (not shown) therethrough. An aperture 27 is formed in thesidewall of the inner shaft 26 distally of the retainer 30 so as toprovide fluid communication between the lumen 25 and a pocket 43 definedbetween the retainer 30 and an insert 40 affixed to the distal tip 14.The inner shaft 26 may optionally be connected to a hub that includes aluer lock coupling, e.g., as shown in FIG. 3.

The distal tip 14 has a guide wire lumen 13 that is axially aligned withthe lumen 25 of the inner shaft 26. A removable plug 28 may be disposedin the distal end of the lumen 13 for creating a liquid-tight seal atthe distal end of the distal tip 14. For example, the plug 28 may bemade of a solid metal having an outer diameter that is about the same asor slightly larger than the inner diameter of the lumen 13, therebyproducing an interference fit between the plug and the lumen.

The distal sheath 24 surrounds the support shaft 21 when the distalsheath covers the compartment 23, and is slidable relative to thesupport shaft such that it can selectively cover or uncover thecompartment. The distal sheath 24 is affixed at its distal end to theinsert 40, and through it to the inner shaft 26 and the distal tip 14.The connection of the distal sheath 24 to the insert 40 thus enables theinner shaft 26 to control the movement of the distal sheath bothproximally and distally. A proximal end 15 of the distal sheath 24 abutsthe retainer 17 when the distal sheath fully covers the compartment 23,as shown in FIG. 1. The proximal edge 15 is spaced apart from theretainer 17 when the compartment 23 is at least partially uncovered.

To use the delivery device 10 to insert the collapsible prosthetic heartvalve 6 into a patient at a desired location, the user can first loadthe valve into the compartment 23 by attaching the aortic end of thevalve to the retainer 30, and crimping the valve to reduce its diametersuch that it fits inside of the distal sheath 24. Examples of suitableretainers and methods of coupling prosthetic valves to such retainersare shown and described in the co-pending application 61/364,453, filedon Jul. 15, 2010, the disclosure of which is hereby incorporated byreference herein.

Next, the user can insert the catheter assembly 16 into a patient, forexample, through an incision in the apex of the patient's heart,advancing the catheter assembly until the distal sheath 24 is positionedin the aortic arch of the patient. The valve 6 may then be deployed atthe desired location by sliding the inner shaft 26 and the distal sheath24 distally relative to the support shaft 21 and the valve 6 coupledthereto, so that the valve will become uncovered and can self-expanduntil released from the delivery device 10.

The catheter assembly 16 is adapted to be flushed with a flushing liquidsuch as saline, although any other appropriate liquid may be used. It isdesirable to flush the compartment 23 and the pocket 43 in order tode-air (i.e., remove air pockets or air bubbles) the area in and aroundthe prosthetic valve 6, and to flush the inner shaft 26 in order toprovide lubrication for a guide wire that may be inserted through theinner shaft during advancement of the delivery device 10 to the targetlocation.

To flush the catheter assembly 16, the user may apply a pressurizedflushing liquid to the proximal end of the lumen 25 of the inner shaft26. A proximal-to-distal pressure gradient in the lumen 25 of the innershaft 26 causes the flushing liquid to travel distally through the lumenof the inner shaft along the path “A” shown in FIG. 1. Because thedistal end of the lumen 13 of the distal tip 14 is plugged with theliquid-tight plug 28, the flushing liquid flows out of the lumen 25 ofthe inner shaft 26 through the aperture 27 and into the pocket 43 alongthe path “B”.

A distal-to-proximal pressure gradient between the pocket 43 and thecompartment 23 within the distal sheath 24 causes the flushing liquid totravel proximally from the pocket along the path “C” around the outerperimeter of the retainer 30 and into the compartment. The flushingliquid continues to travel proximally along the path “C” within thecompartment 23 and out therefrom along the path “D” through acylindrical gap 19 created between the proximal end 15 of the distalsheath and the retainer 17. While the flushing liquid is travelingproximally within the compartment 23, a portion of the flushing liquidflows through the prosthetic valve 6, thereby pushing entrapped airbubbles out of the prosthetic valve. Although the exemplary liquid flowpath “C” is shown extending along only one side of the prosthetic valve6, the liquid will flow proximally throughout the entirety of thecompartment 23 and the valve.

The flushing liquid travels from the proximal end of the inner shaft 26,distally through the inner shaft and out aperture 27, and thenproximally through the pocket 43 and the compartment 23 to thecylindrical gap 19 in a single flushing step because of a pressuregradient in the flushing liquid between the proximal end of the innershaft and the cylindrical gap. Because there is no exposure to theenvironmental pressure external to the delivery device 10 along thepaths A, B, C, and D until the cylindrical gap 19, a pressure above theenvironmental pressure can be maintained along these paths, therebypermitting the lumen 25 of the inner shaft 26, the pocket 43, and thecompartment 23 to be flushed with a pressure sufficient to de-air same.Moreover, since the flushing liquid travels through the inner shaft 26,the pocket 43, and the compartment 23 in a continuous circuit throughthe catheter assembly 16, only a single flushing step may be required toflush the catheter assembly, rather than separate flushing steps for (i)the inner shaft and (ii) the pocket and the compartment.

Referring now to FIG. 2, the distal end of a delivery device 110,similar to that of FIG. 1, is shown with an alternate arrangement forpassing flushing liquid therethrough. In the delivery device 110, theinsert 140 has a distal surface 141 that is spaced from aproximal-facing surface 115 of the distal tip 114. The distal surface141 and the proximal-facing surface 115 define a head space 127therebetween. A plurality of passages 129 may extend through the insert140 and interconnect the head space 127 with the pocket 143 definedbetween the insert 140 and a retainer 130.

The retainer 130 may include one or more through-holes 132 that enable aflushing liquid to flow through the retainer from the pocket 143 to thecompartment 123 during the flushing process. The retainer 130 mayinclude any number and configuration of through-holes 132 that provideliquid communication between the pocket 143 and the compartment 123. Thepresence of the through-holes 132 in the retainer 130 enables a flushingliquid to flow proximally through the retainer, rather than flowingaround the outer edges of the retainer. Such a direct route for theflushing liquid through the retainer 130 may reduce the pressuredifferential in the flushing liquid as the liquid traverses the retaineras compared to the pressure differential that would result from theliquid flowing between the retainer and the distal sheath 124. Thisdifference may permit the use of a lower initial flushing liquidpressure at the proximal end of the inner shaft 126. Other than thereduced pressure differential that may be provided by the through-holes132, the flushing operation of the delivery device 110 is similar to theflushing operation of the delivery device 10 shown and described withreference to FIG. 1.

In a variation of the embodiment shown in FIG. 2, the distal surface 141of the insert 140 may contact the proximal-facing surface 115 of thedistal tip 114, eliminating the head space 127 therebetween. In such avariant, one or more flowpaths may be established in the inner shaft 126and the insert 140 to provide flow communication between the lumen 125of the inner shaft and the plurality of passages 129. The flowpath maybe in the form of an open reservoir extending through the entirecircumference of the inner shaft 126 and through the insert 140 up tothe passages 129. Alternatively, the flowpath may be in the form of aplurality of radially projecting channels interconnecting the lumen 125with the passages 129.

In another variation of the embodiment shown in FIG. 2, the multiplicityof passages 129 may be merged with one another to form a single passageextending through the insert 140. Such a single passage may be anannular passage that extends partially or substantially continuouslyaround the inner shaft 126. In the variant in which a single annularpassage extends substantially continuously around the inner shaft 126,one or more webs of material or other connections would preferably beprovided between the portion of the insert 140 adjacent the inner shaftand the portion of the insert adjacent the distal sheath 124, so thatthe longitudinal movement of the inner shaft will result in acorresponding movement of the distal sheath. Such a single annularpassage would provide for a greater amount of flow of the flushingliquid from the head space 127 to the pocket 143.

Referring now to FIG. 3, a delivery device 210, similar to that of FIG.1, is shown with another alternate arrangement for passing flushingliquid therethrough. Rather than having a removable plug disposed in thedistal end of the lumen of the distal tip, the delivery device 210includes a cap 228 disposed on a hub 220 located at the proximal end ofthe inner shaft 226 that creates a liquid-tight seal at the proximal endof the inner shaft. With the cap 228 in place, a flushing needle 201 maybe inserted into the open end of the distal tip 214 to introduce aflushing liquid into the delivery device 210. The flushing needle 201may have a needle shaft 202 with an outer diameter that is about thesame size as or slightly larger than the inner diameter of the distalend of the lumen 213 in the distal tip 214, thereby producing aninterference fit between the needle shaft and the lumen.

To flush the delivery device 210, a pressurized flushing liquid isintroduced into the distal end of the lumen 213 of the distal tip 214 bythe flushing needle 201. A distal-to-proximal pressure gradient in thelumen 213 of the distal tip 214 causes the flushing liquid to travelproximally through the lumen of the distal tip and into and through thelumen 225 of the inner shaft 226 along the path A′ shown in FIG. 3.Because the proximal end of the lumen 225 of the inner shaft 226 iscapped with the liquid-tight cap 228, a buildup of pressure in the lumencauses the flushing liquid to flow out of the lumen through an aperture227 therein and into the pocket 243. From the pocket 243, the liquidflows through the compartment 223 and the cylindrical gap 219 alongsubstantially the same paths as paths C and D shown in FIG. 1.

When flushing the delivery device 210, the portion of the lumen 225 inthe inner shaft 226 between the cap 228 and the aperture 227 is merelyfilled with liquid, but may not be adequately flushed. Rather, only thedistal most portion of the lumen 225 of the inner shaft 226 may beflushed along the proximal path A′ taken by the flushing liquid.Therefore, a user may desire to perform a second separate flushing stepby plugging the distal end of the inner shaft as described above withreference to FIG. 1, removing the cap 228 and flushing the inner shaftfrom the proximal end thereof. Alternatively, as this second flushingstep is intended to flush only the lumen 225 of the inner shaft 226, thedistal end of the inner shaft need not be plugged, and the flushingliquid can flow into the proximal end of the inner shaft and out fromthe distal end thereof. Such a second flushing step may provideadditional lubrication of the inner shaft 226 such that a guide wire maybe easily slid therethrough.

In the delivery devices shown in FIGS. 1-3, particular structures areshown that provide liquid communication between the interior of theinner shaft and the pocket within the distal sheath. The invention alsocontemplates the use of any alternative structures that provide suchliquid communication. For example, any number of apertures, spaces,and/or passages may be provided in the delivery device to allow liquidcommunication between the lumen of the inner shaft and the pocket, andsuch apertures, spaces and/or passages may have any shape and may extendat any angle relative to the longitudinal axis of the inner shaft.

Referring now to FIG. 4, a delivery device 310, similar to that of FIG.1, is shown with yet another alternate arrangement for passing flushingliquid therethrough. The delivery device 310 has a passage 328 thatextends from the pocket 343 through the insert 340 and the distal tip314 to the external surface of the distal tip.

A flushing needle 301 may have a needle shaft 302 with an outer diameterthat is about the same size as or slightly larger than the diameter ofthe passage 328 extending through the distal tip 314, thereby producingan interference fit between the needle shaft and the passage.Preferably, the distal tip 314 is made from a soft material such aspolyether block amide (Pebax®), such that the passage 328 can self-sealupon withdrawal of the needle shaft 302 to a sufficient degree that theliquid contained in the pocket 343 will not flow out through the passageduring typical use of the delivery device 310 to deliver the valve 306into a patient.

To flush the delivery device 310, a pressurized flushing liquid isintroduced into the passage 328 by the flushing needle 301. Adistal-to-proximal pressure gradient in the passage 328 causes theflushing liquid to travel proximally through the passage and into thepocket 343 along the path A″ shown in FIG. 4. From the pocket 343, theflushing liquid flows through the compartment 323 and the cylindricalgap 319 along substantially the same paths as paths C and D shown inFIG. 1.

When flushing the pocket 343 and the compartment 323 of the deliverydevice 310, the inner shaft 326 is not flushed. Accordingly, a user maydesire to perform a second separate flushing step of flushing the innershaft 326 from the proximal end or the distal end thereof. It should beappreciated that since the inner shaft 326 is not flushed when thepocket 343 and the compartment 323 are flushed, a variant of thedelivery device 310 may be provided including a solid inner shaft thatdoes not have a lumen. In such a variant delivery device, the process offlushing the pocket 343 and the compartment 323 would be the same asthat described above.

The invention also contemplates the use of any alternative structuresthat provide liquid communication between the external environment andthe pocket within the distal sheath. For example, an aperture or one ormore passages may be provided in one or more of the distal tip 314, theinsert 340, and the distal sheath 324 to allow liquid communicationbetween the external environment and the pocket, and such apertureand/or passages may have any shape and may extend at any angle relativeto the longitudinal axis of the inner shaft.

Although the various delivery devices have been described here inconnection with deployment of a prosthetic valve having a collapsiblestent structure, all of the delivery devices may be used for otherpurposes. In particular, the various delivery devices may be used toretain and deliver conventional collapsible stents that do not contain avalve.

Although the invention herein has been described with reference toparticular embodiments in which the annulus end of a prosthetic valve isdeployed first, it is to be understood that the invention contemplatesembodiments in which the aortic end of a valve is deployed first. Insuch embodiments, the annulus end of the stent portion of the valve maybe engaged with a retainer, while the aortic end of the stent may beremote from the retainer and may be unsheathed first.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

The invention claimed is:
 1. A delivery device for a collapsibleprosthetic heart valve, the delivery device comprising: a support shaftaround which a compartment is defined, the compartment being adapted toreceive the valve in an assembled condition; an inner shaft extendingthrough the support shaft and adapted to slide relative to the supportshaft along a longitudinal axis thereof, the inner shaft having a lumentherethrough; a distal tip operatively connected to a distal end of theinner shaft; a distal retainer interposed between the distal tip and thecompartment; a pocket defined between the distal retainer and the distaltip; a distal sheath operatively connected at a distal end thereof tothe inner shaft and slidable therewith, the distal sheath being adaptedto selectively cover and uncover the compartment and the valve; and afirst flow path providing flow communication between the lumen of theinner shaft and the compartment, the first flow path including anaperture in a wall of the inner shaft providing flow communicationbetween the lumen of the inner shaft and the pocket, the aperture beinglocated between the distal retainer and the distal tip.
 2. The deliverydevice of claim 1, further comprising a second flow path providing flowcommunication between the pocket and the compartment.
 3. The deliverydevice of claim 2, wherein the second flow path includes at least onethrough-hole in the distal retainer.
 4. The delivery device of claim 1,further comprising: a proximal retainer located at a proximal end of thecompartment; and a cylindrical gap defined between a free end of thedistal sheath and the proximal retainer.
 5. The delivery device of claim1, wherein the first flow path provides flow communication from thelumen of the inner shaft through the entirety of the valve.
 6. Adelivery device for a collapsible prosthetic heart valve, the deliverydevice comprising: a support shaft around which a compartment isdefined, the compartment being adapted to receive the valve in anassembled condition; an inner shaft extending through the support shaftand adapted to slide relative to the support shaft along a longitudinalaxis thereof, the inner shaft having a lumen therethrough; a distal tipoperatively connected to a distal end of the inner shaft; a distalretainer interposed between the distal tip and the compartment; a pocketdefined between the distal retainer and the distal tip; an insertdisposed in the pocket and defining an empty space between the insertand the distal tip, the empty space being in flow communication with thelumen of the inner shaft, the insert including one or more liquidpassages extending between the empty space and the pocket; a distalsheath operatively connected at a distal end thereof to the inner shaftand slidable therewith, the distal sheath being adapted to selectivelycover and uncover the compartment and the valve; and a first flow pathproviding flow communication between the lumen of the inner shaft andthe compartment, the first flow path including the empty space, the oneor more liquid passages, and an aperture of the one or more liquidpassages providing flow communication between the lumen of the innershaft and the pocket, the aperture being located between the distalretainer and the distal tip.
 7. A delivery system including the deliverydevice of claim 6, wherein the lumen of the inner shaft is in flowcommunication with an exterior of the delivery device, the deliverysystem further comprising a removable plug adapted for connection to thedelivery device to occlude the flow communication between the lumen ofthe inner shaft and the exterior of the delivery device.
 8. A deliverydevice for a collapsible prosthetic heart valve, the delivery devicecomprising: a support shaft around which a compartment is defined, thecompartment being adapted to receive the valve in an assembledcondition; an inner shaft extending through the support shaft andadapted to slide relative to the support shaft along a longitudinal axisthereof, the inner shaft having a lumen therethrough; a distal sheathhaving a distal end operatively connected to the inner shaft andslidable therewith, the distal sheath being adapted to selectively coverand uncover the compartment and the valve; and a distal tip operativelyconnected to a distal end of the inner shaft, the distal tip having apassage therein providing flow communication between an exterior of thedelivery device and the compartment, wherein the passage is adapted toself-seal such that liquid can not flow therethrough from thecompartment to the exterior of the delivery device.
 9. A delivery systemfor a collapsible prosthetic heart valve, the delivery system includinga delivery device and a removable plug, the delivery device comprising:a support shaft around which a compartment is defined, the compartmentbeing adapted to receive the valve in an assembled condition; an innershaft extending through the support shaft and adapted to slide relativeto the support shaft along a longitudinal axis thereof, the inner shafthaving a lumen therethrough in flow communication with an exterior ofthe delivery device; a distal tip operatively connected to a distal endof the inner shaft; a distal retainer interposed between the distal tipand the compartment; a pocket defined between the distal retainer andthe distal tip; a distal sheath operatively connected at a distal endthereof to the inner shaft and slidable therewith, the distal sheathbeing adapted to selectively cover and uncover the compartment and thevalve; and a first flow path providing flow communication between thelumen of the inner shaft and the compartment, the first flow pathincluding an aperture in a wall of the inner shaft providing flowcommunication between the lumen of the inner shaft and the pocket, theaperture being located between the distal retainer and the distal tip,wherein the removable plug is adapted for connection to the deliverydevice to occlude the flow communication between the lumen of the innershaft and the exterior of the delivery device.
 10. The delivery systemof claim 9, further comprising a removable cap adapted for connection toa proximal end of the inner shaft to create a liquid-tight seal at theproximal end of the inner shaft.
 11. The delivery system of claim 9,further comprising a flushing needle having a hollow needle shaftadapted to supply a flushing liquid to the compartment through thedistal tip.
 12. The delivery system of claim 9, further comprising asecond flow path providing flow communication between the pocket and thecompartment.
 13. The delivery system of claim 12, wherein the secondflow path includes at least one through-hole in the distal retainer.